Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01833598
First received: April 12, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a person's ability to perform daily activities and recreation. Traditional conservative treatments include activity modification, exercises, ice/heat, and medications and corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which the affected area is repetitively needled to disrupt pathological tissue and induce bleeding. This turns a nonhealing chronic injury into an acute injury with enhanced healing capability. Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the affected area, also activating growth factors. There has been promising research in these tendinopathy treatments but more research is needed.

The investigators plan to expand on prior studies to identify a reproducible and efficacious treatment for chronic tendinopathy to reduce pain and improve function and quality of life. Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT with peritendinous PRP as a treatment for chronic tendinopathy.


Condition Intervention
Chronic Tendinopathy
Procedure: PNT + PRP
Procedure: PNT alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of Ultrasound Guided Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Pain [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activity Level [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  • Activity Level [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  • Activity Level [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  • Activity Level [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  • Activity Level [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  • Complications [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  • Complications [ Time Frame: Weeks 4 ] [ Designated as safety issue: Yes ]
    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  • Complications [ Time Frame: Weeks 6 ] [ Designated as safety issue: Yes ]
    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  • Complications [ Time Frame: Weeks 8 ] [ Designated as safety issue: Yes ]
    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  • Complications [ Time Frame: Weeks 12 ] [ Designated as safety issue: Yes ]
    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke


Estimated Enrollment: 86
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PNT + PRP
percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
Procedure: PNT + PRP
The PNT + PRP group will undergo needle tenotomy under direct and continuous ultrasound guidance with even distribution of PRP into the peritendinous area(s) of PNT around the affected tendon.
Other Name: percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
Active Comparator: PNT alone
percutaneous needle tenotomy alone
Procedure: PNT alone
The PNT group will undergo needle tenotomy under direct and continuous ultrasound guidance local anesthesia into the affected tendon. 10 minutes after the injection, the ultrasound machine probe will be passed over the areas treated both to evaluate for any structural changes and for any complications.
Other Name: percutaneous needle tenotomy alone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18-100 years
  • have pain (≥ 5/10 pain on the VAS) that is a direct result of tendinopathy as determined by history of injury and study team member physician's best judgment,
  • ≥3 months of pain after injury that has failed conservative treatments or after corticosteroid (CSI) (must be 3 months after CSI to avoid theoretical tendon rupture)

Exclusion Criteria:

  • are taking coumadin, have a known coagulopathy or bleeding dyscrasia listed by patient report (patients will be asked if they have a bleeding disorder) and/or past medical history (PMH)
  • are taking fluoroquinolones
  • have undergone prior PNT or PRP for the affected tendon(s)
  • have a known systemic illness such as vasculitis, an autoimmune or an inflammatory disease, uncontrolled diabetes, presence of other musculoskeletal injury or tendon rupture, or are or plan to become pregnant during the study.

    • Patients taking aspirin or NSAIDs are not excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833598

Contacts
Contact: Alexandra Voigt 212-659-9379 Alexandra.voigt@mountsinai.org

Locations
United States, New York
Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Jonathan Kirschner, MD    212-659-9359    jonathan.kirschner@mountsinai.org   
Principal Investigator: Jonathan Kirschner, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Jonathan Kirschner, MD Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01833598     History of Changes
Other Study ID Numbers: GCO 12-0656, HS# 12-00346
Study First Received: April 12, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Chronic tendinopathy
platelet rich plasma
tendonitis
percutaneous tendon tenotomy
pain
shoulder
knee
ankle
foot

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014